DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Your Mood, Energy, and Sleep Claims Might Be Regulated
A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing often becomes bolder, and that’s where risk creeps in. The FDA steps in when your claims imply treating or preventing a disease, which can flip your product into drug or device territory. The FTC expects every wellness claim to be truthful and supported by real evidence. In this episode, I explain how I review labels, websites, and social content, map each claim to the right regulatory bucket, and draft compliant alternatives that keep your marketing appealing without triggering expensive oversight. I also build claim checklists to help teams avoid drift in the future. Call, click, or email if you need support.
www.kulkarnilawfirm.com
Is my product a wellness claim or does it fall under FDA and FTC regulation? So many companies start with general wellness claims, improving mood, energy, sleep, but they grow, and then marketing gets bolder. And that's that's where trouble begins. The FDA classifies products as drugs or devices for the most part. If they claim to treat, cure, or prevent a disease state, you're likely to fall within one of those two categories. The FTC requires all claims, wellness or otherwise, to be truthful and backed by evidence. Here's what I do. I tend to look at the claims you have. I'm looking at it across labels, websites, social media, and then mapping those claims against FDA or FTC categories. Now, if a claim crosses into risky territory, I draft compliant alternatives, I work with you to do this. I'm not doing this on my own. The goal is to keep your marketing appealing without adding costly regulatory burdens. I also create claim checklists, if you may need them for your marketing team, to avoid unintentional drift in the future. Call, click, or email.